The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Glaucoma Clinical Trial

Official title:

The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020705
• Other study ID #: OMK20115
• Status: Completed
• Phase: N/A
• Start date: September 22, 2015
• Est. completion date: March 19, 2019

Study information

• Verified date: July 2019
• Source: Istituto di Ricerca Neuroftalmologia S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.

Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.

All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).

The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).

The secondary objective is to assess the tolerability and safety of OMK1 eye drops.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.

• Patients with -2 < MD < -15 dB, progression of MD at least -0,5 dB/y for 2 years.

• Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.

• Patients over the age of 18 years

Exclusion Criteria:

• Patients with contraindications to citicoline

• Patients with IOP higher than 18 mmHg

• Patients with other forms of glaucoma

• Patients treated with other neuroprotective therapies

• Women who are pregnant and/or breastfeeding

• Pediatric or adolescent patients aged under 18 years

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Citicoline eye drops (OMK1)
(OMK1) will be prescribed in the dosage of 1 drop 3 times a day

Other:
• Placebo Comparator: hypromellose based ocular lubricant
will be prescribed in the dosage of 1 drop 3 times a day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istituto di Ricerca Neuroftalmologia S.r.l.	University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glaucomatous damage	The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure.	Baseline and Visit at 36 months
Secondary	progression of glaucoma in the SD OCT examination	assessment of the progression of glaucoma in the SD OCT examination (Retinal Nerve fiber Layer- RNFL evaluation) in the group that receives the topical citicoline together with ocular antihypertensive drug therapy compared to the group treated with the sole reduction of intraocular pressure.; It will be used for the assessment of the progression of glaucoma the Brusini staging system.	Baseline and Visit at 36 months